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Arthrex® AR-7289R

by Arthrex, Inc.

Ref AR-7289R

Arthrex® AR-7289R is a device classified as Class IIb in the EU and Class II in the US made by Arthrex, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 0888867RdpqFbrTpCrclgStVB) and listed in FDA GUDID since 15 Sep 2023 (UDI-DI 00888867392045), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888867RdpqFbrTpCrclgStVB Basic UDI-DI 00888867392045UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867392045 UDI-DI Date15 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888867RdpqFbrTpCrclgStVB registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00888867392045 listed 15 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867392045
  2. Registered EUDAMED 0888867RdpqFbrTpCrclgStVB

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Arthrex®
Generic name
Surgical support tape, non-bioabsorbable
Device name
Radiopaque FiberTape Cerclage Sutures
Model / Ref / Catalog
AR-7289R
Primary DI / UDI-DI
00888867392045
Basic UDI-DI
0888867RdpqFbrTpCrclgStVB
FDA product code
GAT, JDQ
EMDN code
H0102010299 Synthetic nonabsorbable multifilament sutures - other
GMDN term
Surgical support tape, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.5000, 888.3010
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical support tape, non-bioabsorbable

Similar devices in this category

Other devices filed under SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)